Data Presented at Late-Breaking Emerging Technologies Session at the American College of Cardiology’s 58th Scientific Sessions
Minneapolis and Orlando, Fla. – March 30, 2009 – CVRx announced today that longer-term data from early Rheos clinical studies show significant reductions in hypertension and improvements in heart structure and function. The Rheos® Hypertension System, developed by the Minneapolis-based company, is the first device designed to treat hypertension, a leading cause of heart and kidney disease, stroke and death. The Rheos System activates the carotid baroreflex, the body’s own system for regulating blood pressure, and may provide a future treatment option for the millions of people who cannot control their high blood pressure (hypertension) with medications.
“We continue to see favorable clinical results that build on earlier findings from the Rheos clinical studies,” said Dr. Marcos Rothstein, Professor of Medicine, Division of Renal Diseases, Washington University School of Medicine. “We are optimistic that this novel therapy could offer a new treatment option to patients with drug-resistant high blood pressure. I am impressed with the impact this therapy has had on my patients. Many of them are now able to participate in daily activities that they could not do with uncontrolled blood pressure. ”
Two-year and three-year data from European and U.S.early clinical studies evaluating the safety and clinical effectiveness of the Rheos System were presented today by Dr. Rothstein, as part of the Late-Breaking Clinical Trials III: Emerging Technologies Session (Session No. 407) at the 58th Annual Scientific Session of theAmericanCollege of Cardiology (ACC). The findings show a significant reduction in blood pressure in patients with drug-resistant hypertension who have a systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including a diuretic. The trials are assessing the safety and clinical efficacy of the Rheos System.
The presentation at ACC reported on office cuff measurement results after two and three years of active Rheos Therapy for the first European andU.S.patients enrolled in these trials at 11 medical centers: After three years of active Rheos treatment, systolic blood pressure was reduced by an average of 31 mmHg in 22 patients. The Rheos implants were well tolerated.
One-Year Data Show Improved Heart Structure and Function with CVRx Rheos Therapy
Additional clinical data presented in a poster at ACC demonstrate that continuous use of Rheos Therapy in 33 Stage II hypertension patients (systolic blood pressure > 160 mmHg) improves left atrial and ventricular chamber size and dimension and improves diastolic filling velocities. These benefits were incremental to those achieved with aggressive medical therapy. Specifically, Rheos Therapy decreased the size of the heart (left ventricular mass and left atrial dimension) and decreased diastolic blood flow velocities which would suggest an improvement in left ventricular filling pressure over a 12-month period. These changes reduce the amount of energy the heart uses to meet the needs of the body, and decreases stress on the heart. A feasibility study is now under way to assess potential benefit of Rheos Therapy in advanced heart failure patients.
Dr. John Bisognano, Professor of Medicine and Director of Cardiac Rehabilitation and Clinical Preventive Cardiology at the University of Rochester, will present these study results (Abstract No. 1051-168) in Poster Session No. 1051 on Myocardial Function/Heart Failure – Clinical Nonpharmacological Treatment, March 31 at 9:30-10:30 a.m. ET. The title of the abstract is: “Improved Cardiac Structure and Diastolic Flow Velocities in Early-Stage Heart Failure with Chronic Treatment Using an Implantable Device: Results from European and United States Trials of the Rheos System.”
The Rheos System: Working with the Body’s Own Mechanisms to Reduce High Blood Pressure and Treat Heart Failure
The Rheos System uses the CVRx-patented Baroreflex Activation Therapy® technology that is designed to activate the carotid baroreceptors, central components of the body’s natural cardiovascular regulation system. When the baroreceptors are activated, signals are sent through neural pathways to the brain and interpreted as a rise in blood pressure. The brain works to counteract this perceived rise in blood pressure by sending signals to other parts of the body (heart, blood vessels and kidneys) that relax the blood vessels and inhibit the production of stress-related hormones. These changes enable the heart to increase blood output, while maintaining or reducing its workload, thereby reducing blood pressure when it is elevated and alleviating the symptoms of heart failure.
The Rheos System includes the following components:
A small device that is implanted under the collar bone;
•Two thin lead wires that are implanted at the left and right carotid arteries and connected to the pulse generator; and
•The Rheos Programmer System, an external device used by doctors to noninvasively regulate the activation energy from the generator to the lead wires.
About Heart Failure
In heart failure, heart function is impaired, resulting in shortness of breath, exercise intolerance and fluid retention. In the United States, heart failure is estimated to affect 5.7 million adults. Overall, heart failure is associated with a four-fold increased risk in death and a six to nine times increased risk of sudden cardiac death. The estimated direct and indirect costs of heart failure total $37.2 billion annually in the United States.1
Hypertension causes an estimated one in eight deaths worldwide.1 In the United States alone, high blood pressure affects approximately 73.6 million people.1 Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.2, 3 Each incremental increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal levels is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes.
U.S. Rheos Hypertension Pivotal Trial in Progress
CVRx received investigational device exemption (IDE) approval from the FDA to begin the Rheos Pivotal Trial to evaluate the safety and effectiveness of the Rheos System in treating hypertension. The trial is enrolling 300 patients at multiple clinical sites in the United Statesand in Europe. Prospective patients can call (888) 8BP-RISK (827-7475) or visit www.bloodpressuretrial.com, to learn more about the clinical trial. The use of the Rheos device is increasing, with over 200 patients having a Rheos device implanted.
Editor’s Note: Blood pressure is typically recorded as two numbers – the systolic pressure (top number) over the diastolic pressure (bottom number). The systolic pressure is the pressure of blood in the vessels when the heart contracts. Diastolic pressure is the pressure of the blood between heartbeats, when the heart is at rest and is refilling.
About CVRx, Inc.
CVRx, Inc. is a private company founded in 2001 and is headquartered in Minneapolis. The company has developed the Rheos System, an implantable system designed to treat hypertension and heart failure. The system uses CVRx-patented Baroreflex Activation Therapy technology, which activates the carotid baroreceptors, central components of the body’s natural cardiovascular regulation system. For more information, visit www.cvrx.com.
CVRx, Inc.9201 West Broadway Avenue, Suite 650Minneapolis,MN 55445www.cvrx.com
1 Heart Disease and Stroke Statistics. American Heart Association – 2009 Update.
2 Lancet 2002;360:1903-1913.
CAUTION: CVRx Rheos System is an investigational device and is limited by Federal (orUnited States) law to investigational use only.
CVRx, Rheos, Baroreflex Activation Therapy and BAT are trademarks of CVRx, Inc.
© CVRx, Inc. 2009. All rights reserved.